Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions

Christopher Kaeding

Status: Terminated

Conditions: Articular Cartilage Disorder of Knee

Treatments: Device: Mechanical Debridement; Device: Radiofrequency-Based Debridement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03678948

2018H0244

Details and patient eligibility

About

The purpose of this study is to evaluate the changes in clinical and imaging outcomes following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or Mechanical Debridement in subjects 18-50 years of age.

Full description

This is a non-inferiority, prospective, single blinded, randomized, single-center study design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study). The sample size of 82 participants was calculated from a power analysis. The study was powered to detect at least a seven point change in KOOS pain score based on achieving 80% statistical power to detect a non-inferiority margin. Study duration will be until the last subject enrolled reaches 52 weeks post-operative.

The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand treatment group or mechanical debridement treatment group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy, the blinded assignment will be revealed to the subject.

Enrollment: 6 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Given written informed consent on the IRB approved consent form specific to the study, prior to study participation

• 18-50 years old

• Male or Female

• Suspected chondral damage in the following locations where debridement is indicated:

  • Medial femoral condyle
  • Lateral femoral condyle
  • Trochlea
  • Patella

• < 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg)

• 1 or more chondral lesion(s) as noted on MRI

Exclusion criteria

• Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable)

• Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI, MACI, OATs)

• Concomitant procedures that are not allowed:

  • Lateral retinacular release
  • Excision of osteophytes
  • Subchondroplasty
  • Manipulation under anesthesia
  • ACL reconstruction
  • Quad tendon repair
  • Patellar tendon repair
  • Patellar tendon debridement
  • Multiligament reconstruction

• Pregnant and/or intending to become pregnant during this study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

6 participants in 2 patient groups

Radiofrequency-Based Debridement

Active Comparator group

Description:

The Smith and Nephew WEREWOLF COBLATION System is indicated for all soft tissue types in the knee. The WEREWOLF COBLATION System is a FDA cleared bipolar, radiofrequency electrosurgical system designed for use in orthopaedic/arthroscopic surgical procedures.

Treatment:

Device: Radiofrequency-Based Debridement

Mechanical Debridement

Active Comparator group

Treatment:

Device: Mechanical Debridement